Biohaven Ltd. announced preliminary analyses and positive biomarker data from Biohaven's exploratory Phase 1 electroencephalogram (EEG) biomarker study, which was presented to epilepsy key opinion leaders at an off-site meeting held during the International Epilepsy Conference 2023 in Dublin, Ireland. The preliminary study results confirm central nervous system (CNS) activity of BHV-7000 at projected therapeutic concentrations, dose-dependent and time-dependent changes in EEG spectral power and are consistent with EEG effects observed with other antiseizure medications (ASMs) approved for the treatment of epilepsy. Biohaven's Phase 3 program in focal epilepsy is anticipated to begin before the end of 2023.

BHV-7000 has been administered at single doses of up to 100 mg and multiple doses of up to 80 mg daily without significant CNS adverse events commonly associated with other ASMs, including a marked lower incidence of somnolence, speech disorder and memory impairment. Based on the results from the EEG study and preliminary safety profile in SAD/MAD trials, along with PK data from a new once-daily extended-release (ER) formulation, Biohaven plans on exploring three oral doses of BHV-7, (once daily 25 mg ER, once daily 50 mg ER, and once daily 75 mg ER) in the Phase 3 focal epilepsy program. This dosing approach with a Kv7 activator will allow for assessment of distinct target concentrations over a wide range, above and below projected efficacious EC50 drug concentrations, not previously feasible with drugs in this class.

In addition, BHV-7000 does not exhibit GABAA receptor positive allosteric molecular activity as seen with ezogabine and similar co mpounds, which may contribute to the poor tolerability of ezogabine. This lack of GABAA receptor activity potentially gives BHV-7000 a wide therapeutic window which, based on dose-dependent clinical responses seen in other ASMs, should translate to improved efficacy without the typical dose dependent side effect profile often seen in patients receiving ezogabine and other anti-seizure medications.